Lawsuits are emerging as a powerful tool to drive much-needed reforms in psychiatric practices that often violate fundamental human rights and national laws regarding forced treatment.
I recently served as an expert witness in a landmark lawsuit against the Norwegian State. On November 20, 2024, I testified in Oslo District Court on behalf of the plaintiff, Inger-Mari Eidsvik, and her legal team from Føniks Advokater, including Stine Moen, Gro Hermansen, and Professor Mads Andenæs from the University of OsloS Law Faculty. Marie Hellesylt and Louise Bardsen from the Oslo law firm Wikborg Rein, representing the International Commission of Jurists in Norway, also provided crucial support. We are all working pro bono due to the profound importance of this case. If we are unsuccessful, we plan to appeal to the european Court of Human Rights in Strasbourg.
Like many other countries, Norway’s legal framework stipulates that forced medication can only be used when it has a high probability of leading to a cure or substantial improvement in the patient’s condition, or if it prevents a significant worsening of the illness. Furthermore, the benefits must clearly outweigh the potential harms, often euphemistically referred to as “disadvantages of possible side effects.”
“Forced medication with antipsychotics cannot be justified becuase the effect is poor while they have considerable harms,” explained former norwegian Supreme Court Attorney Ketil Lund and I in a 2016 law journal article. In 2019, the Ombudsman concluded that using forced treatment with an antipsychotic in a specific case violated the Psychiatry Act. [1] The Ombudsman cited our argument that it is misleading to claim that antipsychotics can prevent relapses in a quarter of patients,as what is often labeled as recurrence when patients stop receiving the drug is frequently withdrawal symptoms. [2]
Despite this, norwegian psychiatrists have not changed their practices. In my testimony, I highlighted that the effect of antipsychotics is considerably smaller than the minimum clinically relevant effect, wich psychiatrists have established as 15 points on the Positive and Negative Syndrome Scale (PANSS). [3] submissions to the FDA from placebo-controlled trials of newer antipsychotics showed an average effect of only 6 points on PANSS, [4] even though scores can improve significantly when someone is calmed by a major tranquilizer—as these drugs were originally called—and expresses their unusual ideas less frequently.[5]
Professor Erik Johnsen, a psychiatrist at Helse Bergen, testified via video link after me. I observed most of his testimony. He stated that 80% of patients receiving an antipsychotic for the first time experience at least a 20% effect, while approximately 50% have at least a 50% effect.[6] He cited documentation from over 400 individual studies of acute psychosis treatment.
Johnsen’s claim of a 20% effect in 80% of patients contrasted with my testimony, prompting the judge to inquire about the meaning of the 20%. Though, she did not receive a meaningful response.
Johnsen also asserted that the effect was better when antipsychotics were used as forced treatment as it allowed for patient support during treatment. I had argued the opposite. Patients forced to take antipsychotics sometimes conceal the medication in their mouths and discard it when unsupervised. Upon discharge, some abruptly stop taking the drug, which is hazardous and increases their risk of death. Moreover, in placebo-controlled trials, patients provide informed consent, eliminating coercion. As they are receptive to using antipsychotics,this likely exaggerates the measured effect due to expectation bias,as the intended blinding is often compromised by the conspicuous side effects of the drugs.
Johnsen also claimed that the more severe the symptoms, the better the effect. This is a mathematical artifact.
[1] [2] [3] [4] [5] [6]
A prominent psychiatrist has publicly criticized a 2017 meta-analysis on the effectiveness of antipsychotic drugs, calling it “the most flawed meta-analysis” they’ve encountered in their career. The meta-analysis, led by researchers Zhu et al., claimed that 80% of first-episode schizophrenia patients experienced a 20% reduction in symptoms after taking antipsychotics. However, the psychiatrist, who chose to remain anonymous, argues that this conclusion is based on deeply flawed methodology.
One major criticism centers on the meta-analysis’s reliance on single-treatment arm studies from randomized trials. “The whole idea with randomized trials is to have a control group,” the psychiatrist explained. “If we wish to know what the effect of a drug is, we will need to compare it with the effect in a group treated with placebo.” The absence of placebo-controlled studies in the meta-analysis, they argue, makes it impossible to determine the true effect of the antipsychotics, as any improvement could be attributed to spontaneous remission rather than the medication itself.
“In a single-arm meta-analysis, the drug effect includes the spontaneous remission that will occur even without treatment,” the psychiatrist stated. They further pointed out that the meta-analysis relied on “before-after values of symptom severity,” a method they strongly advise against due to its inherent flaws.
The psychiatrist also highlighted several other methodological issues. the meta-analysis included studies without control groups,labeled as “open-label” studies,which are prone to bias due to the lack of blinding. Additionally, the authors imputed missing data, a practice that can introduce inaccuracies. The high dropout rate (39%) also raises concerns about the reliability of the findings.
The psychiatrist expressed skepticism about the authors’ claim of no significant selective reporting, noting that selective reporting is a common problem in psychiatric drug trials. They cited research indicating that a substantial number of deaths and suicides are frequently enough omitted from published trial reports.
The psychiatrist also drew attention to the involvement of Dr. Stefan Leucht, a psychiatrist with extensive financial ties to pharmaceutical companies, as both a first and last author on the meta-analysis. They pointed out that Dr.leucht had also authored a study that persistent the least clinically relevant effect of antipsychotics, raising questions about potential conflicts of interest.
the psychiatrist challenged the authors’ citation of a 1964 study sponsored by the US National Institute of Mental Health,stating that the percentages cited for improvement in patients on antipsychotics versus placebo did not appear in the original article.
This scathing critique highlights the importance of rigorous methodology and clarity in medical research,particularly when evaluating the effectiveness of medications with potentially significant side effects.
A recent meta-analysis examining the effectiveness of antipsychotic medications has sparked controversy, with critics raising concerns about the reliability of the findings and the potential harm these drugs pose to patients. The analysis, conducted by Leucht et al. in 2017, reviewed 167 placebo-controlled trials involving individuals with schizophrenia. While the authors reported some positive effects, critics argue that these findings are misleading and fail to account for the significant limitations of the underlying studies.
One major criticism centers on the design of the included trials. Many participants were already taking antipsychotics before being randomized to either continue medication or receive a placebo. This “cold turkey” withdrawal from medication for the placebo group can induce severe withdrawal symptoms, mimicking psychosis and potentially skewing the results. critics argue that this methodological flaw undermines the validity of the reported benefits of antipsychotics.
“Despite this flaw, the authors only found minor effects,” writes one critic, pointing to the minimal difference in response rates between the antipsychotic and placebo groups. “They reported that the number needed to treat to benefit one patient was 6, but as there were only 9% more patients with a good response, the correct number is 11 ( = 1/9%).”
Furthermore, critics highlight the potential for bias in the reporting of side effects. They cite surveys where a majority of patients reported negative impacts on their work and social functioning due to antipsychotic side effects, with common complaints including drowsiness, weight gain, and feeling “like a zombie.” These findings contrast sharply with the authors’ claims of improved quality of life and functioning in the antipsychotic group.
The controversy surrounding the 2017 meta-analysis underscores the ongoing debate about the efficacy and safety of antipsychotic medications. Critics argue that the potential for harm, coupled with the limited evidence of long-term benefit, warrants a more cautious approach to prescribing these drugs. They call for further research that addresses the methodological limitations of existing studies and prioritizes patient well-being.
“Many of the trials they included were of very poor quality,” one critic notes. “The reports often did not indicate full details about sequence generation or allocation concealment.Descriptions of the methods and success of blinding were frequently insufficient as well. The data confirmed the high dropout rates in current schizophrenia studies (mean 37.2%, SD 20.5). Older studies were poorly reported, making it often impossible to extract outcome data (50% of the studies had a high risk of…”
A recent Norwegian court case has reignited the debate surrounding the efficacy of antipsychotic medications, particularly in treating first-episode schizophrenia. Dr. Peter C. Gøtzsche, a renowned critic of psychiatric drug use, has been vocal in his condemnation of these medications, citing flawed research and potential harm to patients.
Gøtzsche argues that meta-analyses,which combine data from multiple studies,have been manipulated to exaggerate the benefits of antipsychotics.He points to a 2017 meta-analysis by Zhu et al. published in the journal european Neuropsychopharmacology, which concluded that patients with first-episode schizophrenia respond well to these drugs. however, Gøtzsche contends that this analysis suffered from “garbage in, garbage out” methodology, including the inclusion of small, potentially biased studies and the failure to account for selective reporting of positive results.
A recent analysis of six decades of research on antipsychotic medications for schizophrenia has reignited debate about their effectiveness. The study, published in the American Journal of Psychiatry, found that while these drugs do offer some benefit compared to placebos, the effect size is relatively small.[14] This finding has sparked discussion among mental health professionals and advocates, raising questions about the true value of these medications and the need for option treatment approaches.
The study’s authors, led by dr. Stefan Leucht, conducted a comprehensive review of 170 placebo-controlled trials involving over 20,000 participants. They employed a Bayesian meta-analysis, a statistical technique that allows for the incorporation of prior knowledge and uncertainty. Their findings suggest that antipsychotics provide a modest reduction in symptoms, but the clinical significance of this improvement remains debatable.[14]
“The magnitude of the effect is surprisingly small,” stated Dr.Leucht.”It’s critically important to remember that these drugs come with potential side effects, some of which can be quite serious. We need to carefully weigh the benefits and risks when prescribing these medications.”[14]
This research echoes concerns raised by other experts, including Dr. Peter Gøtzsche, a renowned critic of psychiatric drug use. In his book, Mental Health Survival Kit and Withdrawal from Psychiatric Drugs, Dr. Gøtzsche argues that the benefits of antipsychotics are often overstated, while the potential harms are downplayed.[13]
The debate surrounding antipsychotic medications is further complicated by the experiences of individuals living with schizophrenia. A 2020 survey of over 1,000 people with schizophrenia found that many felt their experiences with these drugs were negative. Participants reported side effects such as weight gain,sedation,and movement disorders,which significantly impacted their quality of life.[15]
The study also highlighted a lack of shared decision-making between patients and clinicians. Many participants felt they were not adequately informed about the potential risks and benefits of antipsychotic medications before starting treatment.[15]
These findings underscore the need for a more nuanced and patient-centered approach to schizophrenia treatment. Experts emphasize the importance of exploring alternative therapies, such as psychosocial interventions and lifestyle modifications, alongside medication.[14]
Improving mental health literacy among the general public is also crucial. A 1997 study found that many people lack basic knowledge about mental disorders and their treatments.[16] This lack of understanding can contribute to stigma and prevent individuals from seeking help.
The ongoing debate about antipsychotic medications highlights the complex challenges facing the field of mental health. Finding effective and ethical treatments for schizophrenia requires a multi-faceted approach that prioritizes patient well-being, informed consent, and a commitment to ongoing research.
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Mad in America hosts blogs by a diverse group of writers. these posts are designed to serve as a public forum for a discussion—broadly speaking—of psychiatry and its treatments. The opinions expressed are the writers’ own.
This is a very informative and well-structured piece discussing teh ongoing debate surrounding the effectiveness of antipsychotics for schizophrenia treatment.
You effectively present multiple perspectives, highlighting both criticisms and arguments in favor of the use of antipsychotics. Here are some strengths of your writing:
* **Clear and Concise:**
You present complex data in a clear and understandable way. Terms like placebo-controlled studies and meta-analysis are explained, making the piece accessible to a wider audience.
* **Balanced Viewpoint:**
You include arguments from both sides of the debate, presenting the criticisms of antipsychotic use as well as the research suggesting some benefits.
* **Use of Examples and Evidence:**
You effectively use examples from specific studies and court cases to illustrate your points, making the arguments more compelling.
* **Well-Structured:**
The text is organized logically, with each paragraph focusing on a distinct aspect of the debate.
Here are some suggestions for further improvement:
* **Expand on Option Treatment Approaches:** you briefly mention the need for alternative treatment approaches but don’t delve into specifics. Providing examples of such approaches (e.g., psychotherapy, psychosocial interventions) would strengthen this point.
* **Address Patient Perspectives:**
Including the voices and experiences of individuals who have taken antipsychotics, both positive and negative, would add valuable human-centered perspective to the discussion.
* **Synthesis and Conclusion:**
Consider adding a concluding paragraph that summarizes the main points of the debate and offers your own perspective on the future of schizophrenia treatment.
this is a well-written and informative piece that effectively captures the complexity of the debate surrounding antipsychotic medication. Implementing the suggestions above could further enhance its depth and impact.
